Table of Content

1 INTRODUCTION 13
1.1 OBJECTIVES OF THE STUDY 13
1.2 MARKET DEFINITION 13
1.3 MARKET SCOPE 14
1.3.1 MARKETS COVERED 14
1.3.2 YEARS CONSIDERED FOR THE STUDY 14
1.4 CURRENCY 15
1.5 LIMITATIONS 15
1.6 STAKEHOLDERS 15

2 RESEARCH METHODOLOGY 16
2.1 RESEARCH DATA 16
2.1.1 SECONDARY DATA 17
2.1.1.1 Secondary sources 18
2.1.2 PRIMARY DATA 19
2.1.2.1 Key data from primary sources 20
2.1.2.2 Breakdown of primaries 20
2.1.2.3 Key industry insights 21
2.2 MARKET SIZE ESTIMATION 21
2.3 MARKET BREAKDOWN AND DATA TRIANGULATION 23
2.4 ASSUMPTIONS FOR THE STUDY 24

3 EXECUTIVE SUMMARY 25

4 PREMIUM INSIGHTS 28
4.1 ELECTRONIC TRIAL MASTER FILE (ETMF) SYSTEMS: MARKET OVERVIEW 28
4.2 GEOGRAPHIC ANALYSIS: NORTH AMERICAN ETMF MARKET, BY DELIVERY MODE 29
4.3 US: ETMF SYSTEMS MARKET SHARE, BY COMPONENT AND DELIVERY MODE 29
4.4 GEOGRAPHICAL SNAPSHOT OF THE ETMF SYSTEMS MARKET 30

5 MARKET OVERVIEW 31
5.1 INTRODUCTION 31
5.2 MARKET DYNAMICS 31
5.2.1 DRIVERS 32
5.2.1.1 Rising adoption of eTMF systems 32
5.2.1.2 Rising number of clinical trials 32
5.2.1.3 Rising government funding and grants to support clinical trials 33
5.2.1.4 Increasing R&D expenditure by pharma-biotech companies and IT expenditure allocations 34
5.2.2 RESTRAINTS 34
5.2.2.1 Budget constraints 34
5.2.3 OPPORTUNITIES 35
5.2.3.1 Emerging Asian markets 35
5.2.4 CHALLENGES 35
5.2.4.1 Clinical data privacy 35
5.2.4.2 Dearth of skilled professionals for operating eTMF systems 36

6 ETMF SYSTEMS MARKET, BY COMPONENT 37
6.1 INTRODUCTION 38
6.2 SERVICES 38
6.2.1 RELIANCE ON SERVICES WILL REMAIN HIGH IN THE COMING YEARS, ENSURING STRONG GROWTH IN DEMAND 38
6.3 SOFTWARE 40
6.3.1 RISING ADOPTION OF SOFTWARE IS DRIVING HIGH GROWTH IN THE MARKET 40

7 ETMF SYSTEMS MARKET, BY DELIVERY MODE 43
7.1 INTRODUCTION 44
7.2 CLOUD-BASED ETMF 44
7.2.1 CLOUD-BASED ETMF SEGMENT TO REGISTER HIGHER GROWTH DURING
THE FORECAST PERIOD 44
7.3 ON-PREMISE ETMF 46
7.3.1 LACK OF REMOTE ACCESS CAPABILITIES TO RESTRAIN THE DEMAND FOR ON-PREMISE ETMF 46

8 ETMF SYSTEMS MARKET, BY END USER 48
8.1 INTRODUCTION 49
8.2 PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES 49
8.2.1 PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES ARE MAJOR END USERS OF ETMF SYSTEMS 49
8.3 CONTRACT RESEARCH ORGANIZATIONS 52
8.3.1 INCREASING OUTSOURCING OF CLINICAL TRIALS BY PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES TO CROS IS DRIVING THE ADOPTION
OF ETMF SYSTEMS 52
8.4 OTHER END USERS 54

9 ELECTRONIC TRIAL MASTER FILE (ETMF) SYSTEMS MARKET, BY REGION 57
9.1 INTRODUCTION 58
9.2 NORTH AMERICA 60
9.2.1 US 62
9.2.1.1 Favorable government funding scenario and a large number of ongoing clinical trials are driving the adoption of eTMF systems
in the US 62
?
9.2.2 CANADA 64
9.2.2.1 Favorable regulatory conditions and growing partnerships in Canada to support market growth 64
9.3 EUROPE 66
9.3.1 GERMANY 68
9.3.1.1 Germany to register the highest growth in the European eTMF systems market during the forecast period 68
9.3.2 UK 70
9.3.2.1 Growing number of biopharmaceutical and medical device companies to propel the adoption of eTMF systems in the UK 70
9.3.3 FRANCE 71
9.3.3.1 Rising focus on biosimilars to create a potential market for eTMF systems in France 71
9.3.4 REST OF EUROPE 72
9.4 ASIA PACIFIC 74
9.4.1 CHINA 76
9.4.1.1 Growing outsourcing of clinical trials to CROs to support market growth in China 76
9.4.2 JAPAN 77
9.4.2.1 Government initiatives and partnerships among pharmaceutical companies and CROs to drive market growth in Japan 77
9.4.3 REST OF ASIA PACIFIC 79
9.5 REST OF THE WORLD 81

10 COMPETITIVE LANDSCAPE 84
10.1 OVERVIEW 84
10.2 MARKET RANKING OF PLAYERS, 2018 86
10.3 COMPETITIVE LEADERSHIP MAPPING 87
10.3.1 VISIONARY LEADERS 87
10.3.2 INNOVATORS 87
10.3.3 DYNAMIC DIFFERENTIATORS 87
10.3.4 EMERGING COMPANIES 87
10.4 COMPETITIVE SCENARIO 89
10.4.1 SOLUTION DEPLOYMENTS 89
10.4.2 SOLUTION ENHANCEMENTS 89
10.4.3 EXPANSIONS 90
10.4.4 PARTNERSHIPS 90

11 COMPANY PROFILES 91
(Business overview, Products offered, Recent developments, MNM view)*
11.1 VEEVA SYSTEMS 91
11.2 ORACLE CORPORATION 94
11.3 PHLEXGLOBAL 96
11.4 TRANSPERFECT 97
11.5 AUREA SOFTWARE 99
11.6 LABCORP 100
11.7 EPHARMASOLUTIONS 102
11.8 WINGSPAN TECHNOLOGY 103
11.9 MASTERCONTROL 104
11.10 SURECLINICAL 105
*Business overview, Products offered, Recent developments, MNM view might not be captured in case of unlisted companies.

12 APPENDIX 106
12.1 DISCUSSION GUIDE 106
12.2 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 109
12.3 AVAILABLE CUSTOMIZATIONS 111
12.4 RELATED REPORTS 111
12.5 AUTHOR DETAILS 112



List of Figures



FIGURE 1 RESEARCH METHODOLOGY: ELECTRONIC TRIAL MASTER FILE (ETMF) SYSTEMS 16
FIGURE 2 RESEARCH DESIGN 17
FIGURE 3 PRIMARY RESEARCH 19
FIGURE 4 MARKET SIZE ESTIMATION METHODOLOGY: BOTTOM-UP APPROACH 22
FIGURE 5 MARKET SIZE ESTIMATION METHODOLOGY: TOP-DOWN APPROACH 22
FIGURE 6 DATA TRIANGULATION METHODOLOGY 23
FIGURE 7 ELECTRONIC TRIAL MASTER FILE (ETMF) SYSTEMS MARKET SHARE BY DELIVERY MODE, 2018 25
FIGURE 8 ELECTRONIC TRIAL MASTER FILE (ETMF) SYSTEMS MARKET SHARE BY END USER, 2018 26
FIGURE 9 ELECTRONIC TRIAL MASTER FILE (ETMF) SYSTEMS MARKET SHARE BY COMPONENT, 2018 26
FIGURE 10 GEOGRAPHIC SNAPSHOT OF THE ELECTRONIC TRIAL MASTER FILE (ETMF) SYSTEMS MARKET 27
FIGURE 11 RISING ADOPTION OF ETMF SYSTEMS TO DRIVE MARKET GROWTH DURING
THE FORECAST PERIOD 28
FIGURE 12 CLOUD-BASED ETMF ACCOUNTED FOR THE LARGEST SHARE OF
THE NORTH AMERICAN MARKET IN 2018 29
FIGURE 13 SERVICES AND CLOUD-BASED ETMF ACCOUNTED FOR THE LARGEST SHARES
IN 2018 29
FIGURE 14 ASIA PACIFIC TO WITNESS THE HIGHEST GROWTH DURING THE FORECAST PERIOD 30
FIGURE 15 ETMF SYSTEMS MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES 31
FIGURE 16 GLOBAL INCREASE IN THE NUMBER OF CLINICAL TRIALS, 2010–2018 33
FIGURE 17 NORTH AMERICA DOMINATES THE ETMF SYSTEMS MARKET 58
FIGURE 18 NORTH AMERICA: ETMF SYSTEMS MARKET SNAPSHOT 60
FIGURE 19 EUROPE: ETMF SYSTEMS MARKET SNAPSHOT 66
FIGURE 20 ASIA PACIFIC: LABORATORY INFORMATION SYSTEMS MARKET SNAPSHOT 74
FIGURE 21 ROW: ETMF SYSTEMS MARKET SNAPSHOT 82
FIGURE 22 KEY DEVELOPMENTS IN THE ETMF SYSTEMS MARKET BETWEEN 2016 AND 2019 85
FIGURE 23 ETMF SYSTEMS MARKET RANKING, BY KEY PLAYER (2018) 86
FIGURE 24 ETMF SYSTEMS MARKET, COMPETITIVE LEADERSHIP MAPPING, 2018 88
FIGURE 25 VEEVA SYSTEMS: COMPANY SNAPSHOT 91
FIGURE 26 ORACLE CORPORATION: COMPANY SNAPSHOT 94
FIGURE 27 LABCORP: COMPANY SNAPSHOT 100

 

List of Tables



TABLE 1 ETMF SYSTEMS MARKET, BY COMPONENT, 2017–2024 (USD MILLION) 38
TABLE 2 ETMF SERVICES MARKET, BY REGION, 2017–2024 (USD MILLION) 39
TABLE 3 NORTH AMERICA: ETMF SERVICES MARKET, BY COUNTRY 2017–2024 (USD MILLION) 39
TABLE 4 EUROPE: ETMF SERVICES MARKET, BY COUNTRY, 2017–2024 (USD MILLION) 40
TABLE 5 ASIA PACIFIC: ETMF SERVICES MARKET, BY COUNTRY, 2017–2024 (USD MILLION) 40
TABLE 6 ETMF SOFTWARE MARKET, BY REGION, 2017–2024 (USD MILLION) 41
TABLE 7 NORTH AMERICA: ETMF SOFTWARE MARKET, BY COUNTRY 2017–2024 (USD MILLION) 41
TABLE 8 EUROPE: ETMF SOFTWARE MARKET, BY COUNTRY, 2017–2024 (USD MILLION) 41
TABLE 9 ASIA PACIFIC: ETMF SOFTWARE MARKET, BY COUNTRY 2017–2024 (USD MILLION) 42
TABLE 10 ETMF SYSTEMS MARKET, BY DELIVERY MODE, 2017–2024 (USD MILLION) 44
TABLE 11 CLOUD-BASED ETMF MARKET, BY REGION, 2017–2024 (USD MILLION) 45
TABLE 12 NORTH AMERICA: CLOUD-BASED ETMF MARKET, BY COUNTRY 2017–2024 (USD MILLION) 45
TABLE 13 EUROPE: CLOUD-BASED ETMF MARKET, BY COUNTRY, 2017–2024 (USD MILLION) 45
TABLE 14 ASIA PACIFIC: CLOUD-BASED ETMF MARKET, BY COUNTRY 2017–2024 (USD MILLION) 46
TABLE 15 ON-PREMISE ETMF MARKET, BY REGION, 2017–2024 (USD MILLION) 46
TABLE 16 NORTH AMERICA: ON-PREMISE ETMF MARKET, BY COUNTRY 2017–2024 (USD MILLION) 47
TABLE 17 EUROPE: ON-PREMISE ETMF MARKET, BY COUNTRY, 2017–2024 (USD MILLION) 47
TABLE 18 ASIA PACIFIC: ON-PREMISE ETMF MARKET, BY COUNTRY 2017–2024 (USD MILLION) 47
TABLE 19 ETMF SYSTEMS MARKET, BY END USER, 2017–2024 (USD MILLION) 49
TABLE 20 ETMF SYSTEMS MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY REGION, 2017–2024 (USD MILLION) 50
TABLE 21 NORTH AMERICA: ETMF SYSTEMS MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2017–2024 (USD MILLION) 50
TABLE 22 EUROPE: ETMF SYSTEMS MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2017–2024 (USD MILLION) 51
TABLE 23 ASIA PACIFIC: ETMF SYSTEMS MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2017–2024 (USD MILLION) 51
TABLE 24 LIST OF PARTNERSHIPS BETWEEN CROS & DRUG MANUFACTURERS 52
TABLE 25 ETMF SYSTEMS MARKET FOR CROS, BY REGION, 2017–2024 (USD MILLION) 53
TABLE 26 NORTH AMERICA: ETMF SYSTEMS MARKET FOR CROS, BY COUNTRY 2017–2024 (USD MILLION) 53
TABLE 27 EUROPE: ETMF SYSTEMS MARKET FOR CROS, BY COUNTRY 2017–2024 (USD MILLION) 53
TABLE 28 ASIA PACIFIC: ETMF SYSTEMS MARKET FOR CROS, BY COUNTRY 2017–2024 (USD MILLION) 54
TABLE 29 ETMF SYSTEMS MARKET FOR OTHER END USERS, BY REGION 2017–2024 (USD MILLION) 55
TABLE 30 NORTH AMERICA: ETMF SYSTEMS MARKET FOR OTHER END USERS, BY COUNTRY, 2017–2024 (USD MILLION) 55
TABLE 31 EUROPE: ETMF SYSTEMS MARKET FOR OTHER END USERS, BY COUNTRY 2017–2024 (USD MILLION) 55
TABLE 32 ASIA PACIFIC: ETMF SYSTEMS MARKET FOR OTHER END USERS, BY COUNTRY, 2017–2024 (USD MILLION) 56
TABLE 33 ETMF SYSTEMS MARKET, BY REGION, 2017–2024 (USD MILLION) 59
TABLE 34 NORTH AMERICA: ETMF SYSTEMS MARKET, BY COUNTRY 2017–2024 (USD MILLION) 61
TABLE 35 NORTH AMERICA: ETMF SYSTEMS MARKET, BY DELIVERY MODE 2017–2024 (USD MILLION) 61
TABLE 36 NORTH AMERICA: ETMF SYSTEMS MARKET, BY COMPONENT 2017–2024 (USD MILLION) 61
TABLE 37 NORTH AMERICA: ETMF SYSTEMS MARKET, BY END USER 2017–2024 (USD MILLION) 62
TABLE 38 US: ETMF SYSTEMS MARKET, BY DELIVERY MODE, 2017–2024 (USD MILLION) 63
TABLE 39 US: ETMF SYSTEMS MARKET, BY COMPONENT, 2017–2024 (USD MILLION) 63
TABLE 40 US: ETMF SYSTEMS MARKET, BY END USER, 2017–2024 (USD MILLION) 63
TABLE 41 CANADA: ETMF SYSTEMS MARKET, BY DELIVERY MODE 2017–2024 (USD MILLION) 64
TABLE 42 CANADA: ETMF SYSTEMS MARKET, BY COMPONENT, 2017–2024 (USD MILLION) 65
TABLE 43 CANADA: ETMF SYSTEMS MARKET, BY END USER, 2017–2024 (USD MILLION) 65
TABLE 44 EUROPE: ETMF SYSTEMS MARKET, BY COUNTRY, 2017–2024 (USD MILLION) 67
TABLE 45 EUROPE: ETMF SYSTEMS MARKET, BY DELIVERY MODE 2017–2024 (USD MILLION) 67
TABLE 46 EUROPE: ETMF SYSTEMS MARKET, BY COMPONENT, 2017–2024 (USD MILLION) 67
TABLE 47 EUROPE: ETMF SYSTEMS MARKET, BY END USER, 2017–2024 (USD MILLION) 68
TABLE 48 GERMANY: ETMF SYSTEMS MARKET, BY DELIVERY MODE 2017–2024 (USD MILLION) 69
TABLE 49 GERMANY: ETMF SYSTEMS MARKET, BY COMPONENT, 2017–2024 (USD MILLION) 69
TABLE 50 GERMANY: ETMF SYSTEMS MARKET, BY END USER, 2017–2024 (USD MILLION) 69
TABLE 51 UK: ETMF SYSTEMS MARKET, BY DELIVERY MODE, 2017–2024 (USD MILLION) 70
TABLE 52 UK: ETMF SYSTEMS MARKET, BY COMPONENT, 2017–2024 (USD MILLION) 70
TABLE 53 UK: ETMF SYSTEMS MARKET, BY END USER, 2017–2024 (USD MILLION) 71
TABLE 54 FRANCE: ETMF SYSTEMS MARKET, BY DELIVERY MODE 2017–2024 (USD MILLION) 71
TABLE 55 FRANCE: ETMF SYSTEMS MARKET, BY COMPONENT, 2017–2024 (USD MILLION) 72
TABLE 56 FRANCE: ETMF SYSTEMS MARKET, BY END USER, 2017–2024 (USD MILLION) 72
TABLE 57 ROE: ETMF SYSTEMS MARKET, BY DELIVERY MODE, 2017–2024 (USD MILLION) 73
TABLE 58 ROE: ETMF SYSTEMS MARKET, BY COMPONENT, 2017–2024 (USD MILLION) 73
TABLE 59 ROE: ETMF SYSTEMS MARKET, BY END USER, 2017–2024 (USD MILLION) 73
TABLE 60 ASIA PACIFIC: ETMF SYSTEMS MARKET, BY COUNTRY, 2017–2024 (USD MILLION) 75
TABLE 61 ASIA PACIFIC: ETMF SYSTEMS MARKET, BY DELIVERY MODE 2017–2024 (USD MILLION) 75
TABLE 62 ASIA PACIFIC: ETMF SYSTEMS MARKET, BY COMPONENT 2017–2024 (USD MILLION) 75
TABLE 63 ASIA PACIFIC: ETMF SYSTEMS MARKET, BY END USER, 2017–2024 (USD MILLION) 76
TABLE 64 CHINA: ETMF SYSTEMS MARKET, BY DELIVERY MODE, 2017–2024 (USD MILLION) 76
TABLE 65 CHINA: ETMF SYSTEMS MARKET, BY COMPONENT, 2017–2024 (USD MILLION) 77
TABLE 66 CHINA: ETMF SYSTEMS MARKET, BY END USER, 2017–2024 (USD MILLION) 77
TABLE 67 JAPAN: ETMF SYSTEMS MARKET, BY DELIVERY MODE, 2017–2024 (USD MILLION) 78
TABLE 68 JAPAN: ETMF SYSTEMS MARKET, BY COMPONENT, 2017–2024 (USD MILLION) 78
TABLE 69 JAPAN: ETMF SYSTEMS MARKET, BY END USER, 2017–2024 (USD MILLION) 79
TABLE 70 ROAPAC: ETMF SYSTEMS MARKET, BY DELIVERY MODE 2017–2024 (USD MILLION) 80
TABLE 71 ROAPAC: ETMF SYSTEMS MARKET, BY COMPONENT, 2017–2024 (USD MILLION) 80
TABLE 72 ROAPAC: ETMF SYSTEMS MARKET, BY END USER, 2017–2024 (USD MILLION) 80
TABLE 73 REST OF THE WORLD: ETMF SYSTEMS MARKET, BY DELIVERY MODE 2017–2024 (USD MILLION) 82
TABLE 74 REST OF THE WORLD: ETMF SYSTEMS MARKET, BY COMPONENT 2017–2024 (USD MILLION) 83
TABLE 75 REST OF THE WORLD: ETMF SYSTEMS MARKET, BY END USER 2017–2024 (USD MILLION) 83
TABLE 76 SOLUTION DEPLOYMENTS 89
TABLE 77 SOLUTION ENHANCEMENTS 89
TABLE 78 EXPANSIONS 90
TABLE 79 PARTNERSHIPS 90